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MELAseal 100 “economic” - Mediq Danmark A/S

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Operating Manual<br />

Package Sealing Device<br />

<strong>MELAseal</strong> ® <strong>100</strong> <strong>“economic”</strong><br />

Dear Doctor:<br />

since SN 03<strong>100</strong>N1981<br />

Thank you very much for the trust which you have shown by purchasing this package sealing device.<br />

For more than 55 years now, MELAG — a medium-sized family-owned and -operated business —<br />

has specialized in the production of sterilization equipment for medical practice. During this period,<br />

420,000 MELAG units sold throughout the world testify to the exceptional quality of our sterilizers.<br />

This package sealing device has also been produced and tested in accordance with the strictest<br />

quality criteria. Please read the operating Instructions. Careful use and maintenance will ensure that<br />

our product has a long working life and maintains its value.<br />

The staff and management of MELAG<br />

We reserve the right to make technical alterations


Content:<br />

1 INSTALLATION ..........................................................................................................................................3<br />

1.1 Overview of appliance..........................................................................................................................3<br />

1.2 Power cable and pressure lever...........................................................................................................3<br />

1.3 Sealing temperature.............................................................................................................................3<br />

1.4 Wall mounting.......................................................................................................................................4<br />

2 EVERY-DAY USE .......................................................................................................................................4<br />

2.1 Sealing procedure ................................................................................................................................4<br />

2.2 Packaging cutter ..................................................................................................................................4<br />

2.3 Working with packaging rolls................................................................................................................5<br />

3 ACCESSORIES ..........................................................................................................................................5<br />

3.1 Unit-mounted reel dispenser "comfort" ................................................................................................5<br />

3.2 Wall-mounted reel dispenser ...............................................................................................................6<br />

3.3 Reel dispenser “standard”....................................................................................................................6<br />

4 SERVICING.................................................................................................................................................6<br />

4.1 Exchanging the pressure rail................................................................................................................6<br />

4.2 Exchanging or turning the cutting blade...............................................................................................7<br />

5 GERMAN DIN REGULATIONS ..................................................................................................................7<br />

5.1 Width of sealed seams and clear space ..............................................................................................7<br />

5.2 Storage life ...........................................................................................................................................8<br />

5.3 VDE regulations ...................................................................................................................................8<br />

6 SPARE PARTS...........................................................................................................................................8<br />

Illustration:<br />

Illustration 1: Overview of appliance.............................................................................................................. 3<br />

Illustration 2: Bottom of the unit Illustration 3: Mounting on the wall ............................................................. 4<br />

Illustration 4: Working with packaging rolls.................................................................................................... 5<br />

Illustration 5: Fastening the unit-mounted reel dispenser "comfort" .............................................................. 5<br />

Illustration 6 Wall-mounted reel dispenser ................................................................................................... 6<br />

Illustration 7 <strong>MELAseal</strong> ® <strong>100</strong> reel dispenser "standard"................................................................................ 6<br />

Illustration 8 Views of the unit for Service..................................................................................................... 7<br />

Page 2 of 8


1 Installation<br />

Operating manual <strong>MELAseal</strong> ® <strong>100</strong><br />

1.1 Overview of appliance________________________________________________<br />

8 7 6<br />

1<br />

2<br />

5<br />

4<br />

3<br />

Illustration 1: Overview of appliance<br />

1 Cutter 5 Knob for temperature regulation<br />

2 Handle 6 Paper guide<br />

3 Main switch 7 Upper rear enclosure hood<br />

4 Signal lamp 8 Upper enclosure front<br />

1.2 Power cable and pressure lever________________________________________<br />

The power cable should be plugged into a 230 V (or only for device variant 110V), 50/60 Hz safety socket<br />

with earthing.<br />

Then switch the power on (Illustration 1 item 3). The <strong>MELAseal</strong> ® <strong>100</strong> will now warm up for about 3 minutes,<br />

and is ready for use when the signal lamp (Illustration 1 item 4) is no longer illuminated.<br />

The pressure handle (Illustration 1 item 2) can be inserted at either the bottom right or bottom left side of the<br />

appliance.<br />

1.3 Sealing temperature _________________________________________________<br />

The <strong>MELAseal</strong> ® <strong>100</strong> has a very precise regulation system for the sealing temperature, which is adjusted by<br />

turning the temperature knob (Illustration 1, item 5). With the transparent packaging material such as<br />

MELAfol ® most commonly used in autoclaves by doctors and dentists (one side paper and one side foil, as<br />

described in DIN 58953 Part 4) the temperature knob (Illustration 1 item 5) should be set to the first third of<br />

the area marked with "MELAFOL". Turning the knob anti-clockwise lowers the heating power, and turning<br />

clockwise increases it. As long as the same packaging material is being used, it is then not necessary to<br />

adjust the sealing temperature again during the sealing operations.<br />

With use of see-through sterilization packaging, the <strong>MELAseal</strong> ® <strong>100</strong> Package Sealing Device always<br />

produces uniform sealing seams with a width of 10 mm (DIN 58953 requires at least 8 mm). This requires,<br />

however, that the operator place the paper side downward onto the sealing rail. Tubular film materials should<br />

not be used, because they tend to adhere to the sealing rail.<br />

Page 3 of 8


!<br />

!<br />

1.4 Wall mounting ______________________________________________________<br />

The <strong>MELAseal</strong> ® <strong>100</strong> "economic" has been prepared for installation on the wall. Use the prepared holes in the<br />

bottom, which you can open by breaking out the metal parts. Use a screw, for example, to break out the<br />

metal plugs toward the outside (see Illustration 3), by gently moving them back and forth at the already<br />

perforated places (Illustration 2, no. 9 + 10). The interval between the holes on the wall is 16.4 cm. Caution:<br />

Be sure to place the device only on walls that are strong enough to support the weight of the unit – and make<br />

sure to use 6 mm wall anchor plugs in the holes, as well as round-head screws (∅ 3.5 mm × 45 mm).<br />

Illustration 2: Bottom of the unit Illustration 3: Mounting on the wall<br />

2 Every-day use<br />

2.1 Sealing procedure ___________________________________________________<br />

When the signal lamp (Illustration 1 item 4) is no longer illuminated you can begin to produce seals.<br />

Warning: The sealing rail is always hot!<br />

Feed in the transparent sterilisation packaging with the paper side downwards. Place the sterilization<br />

package, with the paper side down, under the rear paper guide. Then move the package toward the front<br />

between the pressure bar (top) and the sealing rail (bottom). The sealing pressure is generated by pressing<br />

down the handle (Illustration 4 item 2) until it engages. This ensures that the sealing pressure is maintained<br />

automatically.<br />

Warning: If the handle (Illustration 4 item 2) is not pressed down far enough, sealing pressure may not be<br />

adequate and the quality of the seal can suffer. The handle (Illustration 4 item 2) should not be released<br />

while the seal is being produced, which takes about 4 seconds. The process is terminated by returning the<br />

lever to the vertical starting position, and sealing can be repeated as required, if the main switch is not<br />

switched off.<br />

2.2 Packaging cutter ____________________________________________________<br />

The cutting blade (Illustration 8 item 14) must be dragged quickly and with light pressure across the foil using<br />

the black cutter handle (Illustration 4 item 1), and with the switch handle (Illustration 4 item 2) pressed as far<br />

as it will go. If the blade is moved too slowly then the sterilisation packaging will not be cut properly but will<br />

only wrinkle up. The cutting blade functions when moved to the right and to the left.<br />

Page 4 of 8<br />

9 10


Operating manual <strong>MELAseal</strong> ® <strong>100</strong><br />

2.3 Working with packaging rolls__________________________________________<br />

As shown in Illustration 4, slide the rolls onto the roll mounting rod, position them with the side guides<br />

(Illustration 4 item 20), move the packaging under the rear angled paper guide (Illustration 1 item 6), and<br />

guide them through toward the front, between the sealing rail and the pressure bar. The paper side must be<br />

downward: i.e., it must lie on the sealing rail (down). Then pull the packaging in the required length toward<br />

the front, seal the package, and then cut it off.<br />

Place the objects to be sterilized in the package that you have now made. Guide the open end from the front<br />

between the sealing rail and the pressure bar, and seal the package. The width of the sealing rail enables<br />

you to work with packages up to a width of 250 mm.<br />

1<br />

Illustration 4: Working with packaging rolls<br />

3 Accessories<br />

3.1 Unit-mounted reel dispenser "comfort" _________________________________<br />

The "Comfort" unit-mounted roll-holder (Illustration 4 & Illustration 5) - MELAG item number. 111 - can be<br />

used to save space by mounting the rolls of sterilisation pack directly onto the <strong>MELAseal</strong> ® <strong>100</strong> Package<br />

Sealing Device. The roll-holders come with four side guides (Illustration 4, item 20), which ensure good<br />

guidance of the sterilization packaging rolls. The roll-holder is attached to the rear side of the sealing device<br />

with keyhole borings and brackets (Illustration 5 and Illustration 8 item 13 & 19).<br />

Illustration 5: Fastening the unit-mounted reel dispenser "comfort"<br />

2<br />

20<br />

13<br />

19<br />

Page 5 of 8


!<br />

!<br />

3.2 Wall-mounted reel dispenser __________________________________________<br />

Illustration 6 Wall-mounted reel dispenser<br />

Page 6 of 8<br />

If the <strong>MELAseal</strong> ® <strong>100</strong> Package Sealing Device is<br />

placed against the wall, or if it is mounted directly<br />

on the wall, then it is best to have a wall-mounted<br />

reel dispenser - MELAG item number. 106,<br />

(Illustration 6) - positioned directly above it. The<br />

wall-mounted roll-holder can also be installed in a<br />

wall cupboard above the package sealing device,<br />

and the packaging foil fed through a slit in the<br />

base of the cupboard.<br />

Four (4) side guides are provided for each reel<br />

dispenser, to ensure proper positioning of the rolls<br />

of sterilization packaging.<br />

3.3 Reel dispenser “standard” ____________________________________________<br />

The reel dispenser "standard" – MELAG item number 110 – can be used to hold the packaging role directly<br />

on the <strong>MELAseal</strong> ® <strong>100</strong> Package Sealing Device. This reel dispenser is fixed on the two mounting points on<br />

the rear side of the package sealer (Illustration 7 and Illustration 8 item 13).<br />

Illustration 7 <strong>MELAseal</strong> ® <strong>100</strong> reel dispenser "standard"<br />

4 Servicing<br />

Wall<br />

4.1 Exchanging the pressure rail __________________________________________<br />

Note: Let the appliance cool down first to avoid risk of burns. Then disconnect the appliance from<br />

the mains power supply. This is important for all repairs, maintenance and servicing work.<br />

Loosen the four Phillips screws at the top (Illustration 8 item 11 & 12), and completely remove only the two<br />

screws at the rear (item 12).<br />

Now lightly lift the upper enclosure front (Illustration 1 item 8) and remove the upper rear enclosure hood<br />

(Illustration 1 item 7) toward the rear.<br />

Danger! The cutting blade is very sharp! (Illustration 8 item 14)<br />

Take off the blade holder by unscrewing the two Phillips screws (Illustration 8 item 18) from the blade handle.<br />

The pressure rail (Illustration 8 item 15) is now visible. Now remove the right and the left sides of the<br />

enclosure (they are attached by Velcro-type closures). Unscrew the right and the left studs on the end of the<br />

pressure rail (Illustration 8 item 16), and pull the pressure rail out of the unit to the rear.<br />

Replace the pressure rail, and install it by following the above steps in reverse order.


!<br />

!<br />

Operating manual <strong>MELAseal</strong> ® <strong>100</strong><br />

Install the blade holder and the upper rear enclosure hood again. Be sure to slide the front enclosure hood<br />

(Illustration 8 item 17) in the direction of the arrow. Make sure that the axis of the cutter carriage runs free<br />

and easily in the slot of the cover.<br />

11<br />

17<br />

12<br />

13<br />

19<br />

Illustration 8 Views of the unit for Service<br />

4.2 Exchanging or turning the cutting blade_________________________________<br />

Note: Let the appliance cool down first to avoid risks of burns. Then disconnect the appliance from<br />

the mains power supply. This is important for all repairs, maintenance and servicing work.<br />

Loosen the four Phillips screws at the top (Illustration 8 items 11 & 12), and completely remove only the two<br />

screws at the rear (item 12).<br />

Now lightly lift the upper enclosure front (Illustration 1 item 8) and remove the upper rear enclosure hood<br />

(Illustration 1 item 7) toward the rear.<br />

Danger! The cutting blade is very sharp! (Illustration 8 item 14)<br />

Remove the screw that holds the cutting blade (Illustration 8 item 14). Turn or replace the blade, and fasten it<br />

tightly in place with the screw.<br />

Install the upper rear enclosure hood again. Be sure to slide the front enclosure hood (Illustration 8 item 17)<br />

in the direction of the arrow. Make sure that the axis of the cutter carriage runs free and easily in the slot of<br />

the cover.<br />

5 German DIN regulations<br />

14<br />

5.1 Width of sealed seams and clear space _________________________________<br />

Width of sealed seams<br />

German Standard DIN 58953 Part 7 requires that sealed seams in transparent packaging material should<br />

have a width of at least 8 mm. With a width of 10 mm for its sealed seams, the <strong>MELAseal</strong> ® <strong>100</strong> is<br />

considerably better than this minimum requirement.<br />

DIN 58953 Part 7 specifies that a clear space of at least 30 mm be left below the sealing border between the<br />

sterilisation goods and the seam in order to ensure a perfect seal without wrinkles. This applies both for bags<br />

and transparent material from the roll.<br />

General:<br />

• Do not select packages that are too small.<br />

• Before sealing the packages, make sure to press them together to remove as much air as possible.<br />

• If you wish to seal entire standard tray cassettes, the length of the film package should be at least twice<br />

as long as the standard tray cassette (also see DIN 58953, Part 7). This also applies to the sterilization of<br />

textiles in standard tray cassettes.<br />

18<br />

15<br />

16<br />

Page 7 of 8


5.2 Storage life _________________________________________________________<br />

Guidelines for the length of storage for sterile medical products<br />

Sterile goods packaging Type of packaging storage<br />

unprotected 1)<br />

Paper bags in accordance<br />

with DIN 58 953 Part 4 and heat<br />

resistant and self-sealing<br />

transparent packaging or hoses<br />

made of paper or plastic in<br />

accordance with<br />

DIN 58953 Part 5 or other<br />

equivalent packaging<br />

Sterile goods in single<br />

packaging or twostage<br />

packaging<br />

Sterile-goods store<br />

packaging not opened<br />

or opened and closed<br />

again<br />

Serves as supply for<br />

immediate usage.<br />

Avoid this way of<br />

storage.<br />

Length of storage<br />

5 years 4)<br />

Storage<br />

protected 2)<br />

6 months 3)<br />

1) in accordance with 4.3 a) in DIN 58953-8: 1993-02<br />

2) in accordance with 4.3 b) in DIN 58953-8: 1993-02<br />

3) Exceeding the length of storage for this type of packaging is not recommended for practical and<br />

economical reasons<br />

4) provided that no other maturity was defined by the manufacturer<br />

A comment on the table in Section 8.2 of the DIN standard says:<br />

"The information in the table only represents standard values. These do not mean that longer storage<br />

periods are not possible under particularly favourable storage conditions, or that a longer duration of storage<br />

necessarily leads to the pack contents being re-contaminated during storage, but signify that if these periods<br />

are observed, recontamination of the contents when they are opened and correctly removed is extremely<br />

unlikely."<br />

An additional explanatory note goes into further detail:<br />

"The risk in storing sterile goods is not that micro-organisms may penetrate the sterile goods packaging,<br />

provided that dry storage conditions are ensured and the packaging material has the required germ-proof<br />

qualities, but that when the sterile goods packaging is opened after storage, micro-organisms contained in<br />

dust particles may be stirred up and could re-contaminate the sterile objects when these are removed.<br />

"The extent of dust loading depends upon the dust content of the air and on the duration of storage. For<br />

these reasons the storage period should be kept as short as possible."<br />

5.3 VDE regulations _____________________________________________________<br />

In accordance with current VDE regulations, this appliance is not suitable for use in areas at risk of<br />

explosion.<br />

It should only be serviced by the manufacturer or a specially authorised agent (dealer or customer service).<br />

6 Spare parts<br />

Article Description<br />

10115 Pressure rail<br />

12630 Overheating protection switch<br />

31190 Heating cartridge (up to SN 04<strong>100</strong>N1620)<br />

13680 Heating cartridge (since SN 04<strong>100</strong>N1621)<br />

33730 Main switch<br />

17780 Cutting blade<br />

Article Description<br />

45615 Blade holder<br />

45605 Handle for cutter<br />

59610 Temperature regulation<br />

14405 Knob for temperature regulation<br />

24130 Signal lamp<br />

Page 8 of 8 Rev.: 3 – 08/1313 BA_3_GB_seal<strong>100</strong>eco_abSN03<strong>100</strong>N1981.doc

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